Evidence map›Paper›PMID 38193327›Full record

ArticleJournal of Korean medical science2024

Real-World Eligibility and Cost-Effectiveness Analysis of Empagliflozin for Heart Failure in Korea.

Eui-Soon Kim, Sun-Kyeong Park, Jong-Chan Youn, Hye Sun Lee, Hae-Young Lee, Hyun-Jai Cho, Jin-Oh Choi, Eun-Seok Jeon, Sang Eun Lee, Min-Seok Kim and 13 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Journal of Korean medical science, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01389843 (Registry), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.0field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01389843 completednot on this map

Registry (Prospective Cohort) for Heart Failure in Korea (KorAHF)

TypeobservationalSponsorByung-Hee OhRan2011 to 2018Enrolled5,625ConditionsAcute Decompensated Heart Failure
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

23 authors at 12 institutions in 2 countries.

Eui-Soon Kim *Graduate School of Medical Science and Engineering, Korea Advanced Institute of Science and Technology, Daejeon, Korea.ORCID https://orcid.org/0000-0003-2313-8646
Sun-Kyeong Park *College of Pharmacy, The Catholic University of Korea, Bucheon, Korea.ORCID https://orcid.org/0000-0003-4421-4513
Jong-Chan YounDivision of Cardiology, Department of Internal Medicine, Seoul St. Mary's Hospital, Catholic Research Institute for Intractable Cardiovascular Disease, College of Medicine, The Catholic University of Korea, Seoul, Korea. jong.chan.youn@gmail.com.ORCID https://orcid.org/0000-0003-0998-503X
Hye Sun LeeBiostatistics Collaboration Unit, Yonsei University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0001-6328-6948
Hae-Young LeeDepartment of Internal Medicine, Seoul National University Hospital, Seoul, Korea.ORCID https://orcid.org/0000-0002-9521-4102
Hyun-Jai ChoDepartment of Internal Medicine, Seoul National University Hospital, Seoul, Korea.ORCID https://orcid.org/0000-0002-2779-4037
Jin-Oh ChoiDepartment of Internal Medicine, Sungkyunkwan University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0002-2441-2267
Eun-Seok JeonDepartment of Internal Medicine, Sungkyunkwan University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0002-9946-5611
Sang Eun LeeDepartment of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0002-7290-2463
Min-Seok KimDepartment of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0003-0860-3650
Jae-Joong KimDepartment of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0002-2714-2282
Kyung-Kuk HwangDepartment of Internal Medicine, Chungbuk National University Hospital, Cheongju, Korea.ORCID https://orcid.org/0000-0003-3464-3023
Myeong-Chan ChoDepartment of Internal Medicine, Chungbuk National University Hospital, Cheongju, Korea.ORCID https://orcid.org/0000-0002-0047-0227
Shung Chull ChaeDepartment of Internal Medicine, Kyungpook National University College of Medicine, Daegu, Korea.ORCID https://orcid.org/0000-0002-9871-6976
Seok-Min KangDepartment of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0001-9856-9227
Jin Joo ParkSeoul National University School of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0001-9611-1490
Dong-Ju ChoiSeoul National University School of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0003-0146-2189
Byung-Su YooDepartment of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea.ORCID https://orcid.org/0000-0002-3395-4279
Jae Yeong ChoDepartment of Cardiovascular Medicine, Chonnam National University Medical School, Gwangju, Korea.ORCID https://orcid.org/0000-0002-9393-2821
Kye Hun KimDepartment of Cardiovascular Medicine, Chonnam National University Medical School, Gwangju, Korea.ORCID https://orcid.org/0000-0002-6885-1501
Byung-Hee OhDepartment of Cardiovascular medicine, Incheon Sejong Hospital, Incheon, Korea.ORCID https://orcid.org/0000-0002-9945-4306
Barry GreenbergDepartment of Cardiology, UC San Diego Health System, La Jolla, CA, USA.ORCID https://orcid.org/0000-0002-6605-9385
Sang Hong BaekDivision of Cardiology, Department of Internal Medicine, Seoul St. Mary's Hospital, Catholic Research Institute for Intractable Cardiovascular Disease, College of Medicine, The Catholic University of Korea, Seoul, Korea.ORCID https://orcid.org/0000-0002-7065-3432
Seoul National University · KRUlsan College · KRChonnam National University · KRChungbuk National University Hospital · KRSt. Mary's Hospital · USSungkyunkwan University · KRYonsei University · KRCatholic University of Korea · KRKorea Advanced Institute of Science and Technology · KRKyungpook National University · KRSejong General Hospital · KRUC San Diego Health System · US

Funding

Korea Centers for Disease Control and Prevention 2010-E63003-00Korea Centers for Disease Control and Prevention 2011-E63002-00Korea Centers for Disease Control and Prevention 2012-E63005-00Korea Centers for Disease Control and Prevention 2013-E6300300Korea Centers for Disease Control and Prevention 2014-E63003-01Korea Centers for Disease Control and Prevention 2015-E63003-02Korea Centers for Disease Control and Prevention 2016-ER6303-00Korea Centers for Disease Control and Prevention 2017-ER6303-01National Research Foundation of Korea NRF-2021R1F1A1063430
6 · The paper itself

Abstract

backgroundThe US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approved empagliflozin for reducing cardiovascular mortality and heart failure (HF) hospitalization in patients with both HF with reduced ejection fraction (HFrEF) and HF with preserved ejection fraction (HFpEF). However, limited data are available on the generalizability of empagliflozin to clinical practice. Therefore, we evaluated real-world eligibility and potential cost-effectiveness based on a nationwide prospective HF registry.

methodsA total of 3,108 HFrEF and 2,070 HFpEF patients from the Korean Acute Heart Failure (KorAHF) registry were analyzed. Eligibility was estimated by inclusion and exclusion criteria of EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced) and EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved) trials and by FDA & EMA label criteria. The cost-utility analysis was done using a Markov model to project the lifetime medical cost and quality-adjusted life year (QALY).

resultsAmong the KorAHF patients, 91.4% met FDA & EMA label criteria, while 44.7% met the clinical trial criteria. The incremental cost-effectiveness ratio of empagliflozin was calculated at US$6,764 per QALY in the overall population, which is far below a threshold of US$18,182 per QALY. The cost-effectiveness benefit was more evident in patients with HFrEF (US$5,012 per QALY) than HFpEF (US$8,971 per QALY).

conclusionThere is a large discrepancy in real-world eligibility for empagliflozin between FDA & EMA labels and clinical trial criteria. Empagliflozin is cost-effective in HF patients regardless of ejection fraction in South Korea health care setting. The efficacy and safety of empagliflozin in real-world HF patients should be further investigated for a broader range of clinical applications.

trial registrationClinicalTrials.gov Identifier: NCT01389843.

Indexed as

Heart FailureBenzhydryl CompoundsCost-Effectiveness AnalysisGlucosidesHumansProspective StudiesRepublic of KoreaStroke VolumeUnited StatesBenzhydryl CompoundsempagliflozinGlucosidesCost-Effectiveness AnalysisDrug TherapyEmpagliflozinHeart FailureSGLT2 Inhibitors

Identifiers

PMID38193327
PMCPMC10782045
OpenAlexW4389524850

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.